Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 2:49 PM
Ignite Modification Date: 2025-12-25 @ 1:16 PM
NCT ID: NCT01362959
Description: None
Frequency Threshold: 0
Time Frame: 30 days
Study: NCT01362959
Study Brief: Nicotine Replacement Therapy in the Intensive Care Unit
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Nicotine Replacement None 2 None 4 21 21 21 View
Control None 2 None 11 26 26 26 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Ischaemic colitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Asystole NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
haemorrhagic shock NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Stoma necrosis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Duodenal perforation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hemothorax NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Reintubation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Death due to septic shock NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Death due to respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Death due to hypercapnic coma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Electrolyte disturbance NON_SYSTEMATIC_ASSESSMENT Investigations None View
Gastrointestinal event NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cardiovascular NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pulmonary NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Renal NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other adverse events NON_SYSTEMATIC_ASSESSMENT General disorders None View